Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT00176605
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT00176605
Study Brief: Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 (Etoposide + Cyclophosphamide) Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide. Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration None None 3 15 11 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Valvular heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Ulcer, GI - Anus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Infection with unknown ANC - appendix SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue (astenia, lethary, malaise) SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Constitution Symptoms (Other) SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rigors/chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Sweating (diaphoresis) SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hair loss/alopecia (scalp or body) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pain/ - head/headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - chest/thorax NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mood alteration - depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Neuropathy: sensor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Urinary frequency/urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View